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Effects of Medications in Patients With Hypogonadism

Primary Purpose

Idiopathic Hypogonadotropic Hypogonadism

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Testosterone enanthate (Sustanon 250 mg)
Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)
Testosteron gel (Testojel 50 mg)
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypogonadotropic Hypogonadism focused on measuring hypogonadism, treatment, testis volume

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: hypogonadotropic hypogonadism

  • decreased serum testosterone concentration below the normal range (serum T < 300ng/dL),
  • FSH and LH levels within or below the normal range,
  • absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH,
  • normal smell test and normal karyotypes

Exclusion Criteria:

  • previous androgen treatment,
  • history of smoking,
  • presence of bilateral anorchia,
  • intellectual deficiency,
  • diabetes mellitus,
  • arterial hypertension or dyslipoproteinemia,
  • medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

Participants with iron, vitamin B12 or folate deficiency were also excluded.

Sites / Locations

  • Gulhane School of Medicine Dep. of Endocrine and Metabolism
  • Gulhane School of Medicine Dep. of Endocrinology and Metabolism

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

hypogonadism, treatment

Control group

Arm Description

77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin

42 healthy controls

Outcomes

Primary Outcome Measures

Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.

Secondary Outcome Measures

Effect of testosterone enanthate on testis volumes
Effect of testosterone gel on testis volumes
Effect of human chorionic gonadotrophin on testis volumes

Full Information

First Posted
May 1, 2012
Last Updated
May 17, 2012
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01601327
Brief Title
Effects of Medications in Patients With Hypogonadism
Official Title
Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypogonadotropic Hypogonadism
Keywords
hypogonadism, treatment, testis volume

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypogonadism, treatment
Arm Type
Other
Arm Description
77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin
Arm Title
Control group
Arm Type
No Intervention
Arm Description
42 healthy controls
Intervention Type
Drug
Intervention Name(s)
Testosterone enanthate (Sustanon 250 mg)
Intervention Description
Twenty-eight patients were treated with testosterone enanthate (TE),
Intervention Type
Drug
Intervention Name(s)
Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)
Intervention Description
twenty-five patients were treated with human chorionic gonadotropin (hCG)
Intervention Type
Drug
Intervention Name(s)
Testosteron gel (Testojel 50 mg)
Intervention Description
Twenty-four patients were treated with testosterone gel (TG).
Primary Outcome Measure Information:
Title
Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Time Frame
3 years
Title
Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Time Frame
3 years
Title
Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Effect of testosterone enanthate on testis volumes
Time Frame
3 years
Title
Effect of testosterone gel on testis volumes
Time Frame
3 years
Title
Effect of human chorionic gonadotrophin on testis volumes
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: hypogonadotropic hypogonadism decreased serum testosterone concentration below the normal range (serum T < 300ng/dL), FSH and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell test and normal karyotypes Exclusion Criteria: previous androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded. Participants with iron, vitamin B12 or folate deficiency were also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aydogan Aydogdu, MD
Organizational Affiliation
Gulhane School of Medicine, Department of Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane School of Medicine Dep. of Endocrine and Metabolism
City
Ankara
ZIP/Postal Code
06018
Country
Turkey
Facility Name
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

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Effects of Medications in Patients With Hypogonadism

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